Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral
(unaffected) breast between the aspirin and placebo arms in patients with hormone receptor
negative breast cancer enrolled in A011502.

SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the
contralateral (unaffected) breast between the aspirin and placebo arms in patients with
hormone receptor negative breast cancer enrolled in A011502.

OUTLINE:

Participants provide bilateral screening mammogram taken prior to all cancer treatment and
within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as
possible to 1 year post-registration to A011502 and as near as possible to 2 years
post-registration to A011502. Participants also undergo collection of blood sample and
menstrual cycle data within 2 weeks after registration and at 1 and 2 years after
registration to A011502.

After completion of study, participants are followed up annually until 10 years from
registration to study A011502.

Inclusion Criteria:

- Must be concurrently enrolling to Alliance A011502. Eligible patients may be either
pre- or post-menopausal.

- Patients must have hormone receptor-negative breast cancer.

- Patients must have baseline breast density measurement as defined by one of the
following:

- >= 25% breast density, or

- Scattered areas of fibroglandular density, or

- Breast composition category b, c, or d, per Breast Imaging Reporting and Data
System (BI-RADS) 2013.

- Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views)
taken within 8 weeks prior to registration must be available for submission.

* If baseline mammogram within 8 weeks is not available, a new screening mammogram
must be performed prior to treatment on Alliance A011502. To receive reimbursement for
the cost of this additional mammogram, institutions may submit the A211601
Reimbursement Form, which is available on the Alliance and Cancer Trials Support Unit
(CTSU) web pages.

- Patients receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not
eligible.

- Contralateral unaffected breast in place (with no prior cancer or radiation, no
implants and no plan for breast surgery on contralateral breast over the course of the
study). Patients with a prior biopsy on the unaffected breast are eligible.

- Not pregnant and not nursing.